Impact of Zinc As a New Adjuvant Therapy for Cow Milk Protein Allergy in Children.

Impact of Zinc As a New Adjuvant Therapy for Cow Milk Protein Allergy in Children, a Randomized Controlled Trial

Children presented with manifestations of Cow Milk Protein Allergy will be enrolled for Cow Milk -related Symptoms Score (CoMiSS assessment). Detailed History, nutritional and clinical examination will be done to fulfill items of CoMiSS. Children will be randomly allocated to two groups. Oral Zinc will be supplemented to the interventional group. CoMiSS will be recorded at the baseline and weekly till 4 weeks. Then Oral Food Challenge (OFC) will be done to confirm the diagnosis and CoMiSS assessment will be recorded again to see if Zinc has any modulatory effect on reappearance of symptoms. The people administering the intervention, the people assessing the outcomes, the patients and their caregivers will all be blinded to the type of treatment.

Children who will be presented with skin manifestation will be assessed by Severity Scoring of Atopic Dermatitis Index (SCORAD score) once diagnosed and weekly till 4 weeks after zinc supplementation to see if Zinc has any modulatory effect.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cow Milk Protein Allergy
• Intervention / Treatment: Other: Placebo; Drug: Oral zinc supplementation

Detailed Description

Children who will be presented with manifestations of Cow Milk Protein Allergy will be enrolled in the study for Cow Milk -related Symptoms Score (CoMiSS) assessment.

Detailed History, nutritional and clinical examination will be done to fulfill items of CoMiSS including skin manifestations as eczema , respiratory manifestations, GIT manifestations as constipation or diarrhea including Bristol scale and regurgitations and duration of crying .

Children will be randomly allocated to two groups. Randomization will be done using GraphPad QuickCalcs software to allocate into either the interventional or control group. Oral Zinc will be supplemented to the interventional group on adose of 30 mg elemental zinc/day.

CoMiSS will be recorded at the baseline and weekly till 4 weeks. Then Oral Food Challenge (OFC) will be done to confirm the diagnosis and CoMiSS assessment will be recorded againto see if Zinc has any modulatory effect on reappearance of symptoms. The people administering the intervention, the people assessing the outcomes, the patients and their caregivers will all be blinded to the type of treatment.

Children who will be presented with skin manifestation will be assessed by Severity Scoring of Atopic Dermatitis Index (SCORAD score) once diagnosed and weekly till 4 weeks after zinc supplementation to see if Zinc has any modulatory effect.

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12556
    • faculty of medicine-Cairo universty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Children suspected to have Cow Milk Protein Allergy using Cow's Milk-relatedSymptoms Score with a Score more than12 Age less than 12 years old both sexes Whose parents approved to be enrolled in the study

Exclusion Criteria:

Children with Comorbidities that may affect the duration of treatment as dysphagia.

History of Severe allergic reaction that required hospital admission as Ora Food Challenge is expectedto be delayed in these patients.

-Multiple Food Allergies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: interventional group; Oral Zinc will be supplemented to the interventional group on a dose of 30 mg elemental zinc/day.	Drug: Oral zinc supplementation; Oral Zinc will be supplemented to the interventional group on a dose of 30 mg elemental zinc/day.
Placebo Comparator: control group; oral placebo identical to Zinc inappearance and packaging	Other: Placebo; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COMISS(Cow Milk Related symptom Score)	Evaluate the degree of change in COMISS Sc0re(Cow Milk Related symptom Score) between the interventional group and control group The COMISS Score ranges from 0 to 33. Each symptom has a maximal score of six,exception of respiratory symptoms(maximal score of three). a cut-off value>12 was selected as the criterion to pick up infant at risk of Cow Milk Allergy . A score of 12 requires the presence of at least two severe symptoms and a score higher than10 requires the precense of at least three symptoms and the involvement of two organ systems	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COMISS (Cow Milk Related Symptom Score)and SCORAD (Severity Scoring of Atopic Dermatitis index)	Degree of change clinicaiiy by SCORAD (Severity Scoring of Atopic Dermatitis index) between the intervention and control group upon Zinc adminstration.SCORAD is a clinical tool used to assess the extent and severity of eczema, To determine extent by is the 'rule of nine': 9% for the head and neck, each arm, the front and back of each leg, the four trunk quadrants, and 1% for the genitalia, The intensity part of the index consists of six items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness. Each item can be graded on a scale 0-3 pruritus and sleeplessness (0-10)for each, SCORAD score range is between 0 and 103 points and defines three classes of AD severity (. mild if SCORAD <25, moderate if 25 ≤ SCORAD ≤ 50 and severe if SCORAD > 50.; The Change in the degree of improvement between the interventional and control group based on COMISS score at 1,2, 3, and 4 weeks. 2.Time to improvement of COMISS score below 12 in both groups.	4 Weeks

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital
• Investigators: Principal Investigator: Nabil Abdelaziz, Professor of Pediatrics, Cairo university; Principal Investigator: Dalia Sayed Mosallam, Professor of Pediatrics, Cairo university; Principal Investigator: Hoda Atef Abdel Sattar, Lecturer of Pediatrics, Cairo university

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): April 15, 2025
• Study Completion (Estimated): May 15, 2025

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Zinc; SCORAD; Cow Milk Protein Allergy; COMISS
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: zinc in cow milk allergy; Arwa (Other Identifier: self funding)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No